CiprofolNCT07148596
Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages
An observational study of Ciprofol, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
This study aims to explore dose requirements for loss of consciousness and bispectral index changes during general anesthesia induction with ciprofol in patients of different ages, providing a reference for its rational clinical application. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ciprofol
- What is being tested?
- It is an observational study without any intervention measures.
- Type of treatment
- Injection or infusion
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 7 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 120 patients scheduled for general anesthesia were selected according to inclusion/exclusion criteria, with balanced age distribution and equal gender allocation (60 males and 60 females).
Who may be able to join
- 1) The ASA classification I-II 2) BMI range: 18.5 < BMI ≤ 24.9 kg/m² 3) Scheduled for elective general anesthesia surgery 4) Signed informed consent by the patient or legal guardian
Who cannot join
- 1) Patients with central nervous system disorders or using medications affecting the central nervous system 2) Patients with cardiac, hepatic, pulmonary, or renal dysfunction 3) History of alcohol or drug abuse 4) Allergy to the study drug 5) Patients with hematologic or metabolic diseases 6) Participation in other drug clinical trials within the past 4 weeks 7) Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages: a Single-center, Prospective, Observational Study
This study aims to explore dose requirements for loss of consciousness and bispectral index changes during general anesthesia induction with ciprofol in patients of different ages, providing a reference for its rational clinical application.
Read the detailed description
Ciprofol, a novel gamma-aminobutyric acid (GABA) receptor agonist, is structurally modified from propofol by adding a cyclopropyl group to its side chain, forming an R-type chiral structure. This modification enhances its affinity for GABA receptors, resulting in faster onset, rapid metabolism, higher potency, reduced injection pain, and milder respiratory/circulatory suppression. Ciprofol exhibits good safety and tolerability, smooth and rapid induction, complete recovery, and low incidence of injection pain, making it a promising alternative to propofol. Age is a critical factor influencing general anesthesia and anesthetic drug responses. Age-related changes in organ function affect pharmacokinetics and pharmacodynamics, leading to variations in required drug doses and characteristic electroencephalogram changes. Therefore, this study aims to compare ciprofol doses and BIS changes during general anesthesia induction across age groups, offering reference and guidance for clinical medication.
- Conditions
- Ciprofol
- Being tested
- It is an observational study without any intervention measures.
- Keywords
- Bispectral index, Different ages, Loss of consciousness
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It is an observational study without any intervention measures.Other
All patients will fast for 6 hours and will abstain from drinking for 2 hours preoperatively, with no premedication. Preoxygenation will be performed with an oxygen flow rate of 6 L/min. Ciprofol will be continuously infused via a micropump at a rate of 12 mg/kg/h. During preoxygenation with a facemask, if respiratory depression occurs during ciprofol infusion, assisted ventilation via facemask will be initiated. After LOC and completion of observation indices, the anesthesiologist may administer midazolam (1-3 mg), sufentanil (0.2-0.5 μg/kg), and rocuronium (0.3-0.6 mg/kg) sequentially based on the patient's age, physical condition, and BIS values to complete anesthesia induction. If hypotension (systolic blood pressure <90 mmHg or <80% of baseline) or bradycardia (heart rate <50 beats/min) occurs during induction, vasoactive agents such as ephedrine or atropine will be administered for management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ciprofol dosage
Ciprofol dose required to achieve loss of consciousness. Ciprofol was continuously infused via a micropump at a rate of 12 mg/kg/h. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and loss of eyelash reflex were used to assess sedation depth, with evaluations performed every 5 seconds. A MOAA/S score ≤1 and loss of eyelash reflex were defined as loss of consciousness (LOC).
Measured: During anesthetic Induction
Bispectral index
Bispectral index before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.
Measured: Baseline (Before surgery)
Secondary outcomes (4)
Mean arterial pressure (MAP)
MAP before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.
Measured: up to 3 minutes
heart rate (HR)
HR before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.
Measured: up to 3 minutes
SpO₂
SpO₂ before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.
Measured: up to 3 minutes
Incidence of adverse reactions including respiratory depression and injection pain
Respiratory depression was defined as meeting any of the following criteria: respiratory rate <10 breaths/min, arterial oxygen saturation <90%, arterial partial pressure of carbon dioxide (PaCO₂) ≥50 mmHg, or apnea lasting ≥15 seconds. Injection pain is a subjective discomfort experienced by conscious patients during ciprofol infusion, diagnosed based on clinical manifestations and patient-reported complaints.
Measured: Baseline (Before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CiprofolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148596
- Sponsor's protocol ID
- Yue Wen-2025-04
- Status last verified
- Aug 2025
- First submitted
- 5 May 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages: a Single-center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07148596
- Acronym / sponsor ID
- Yue Wen-2025-04
- Conditions
- Ciprofol
- Keywords
- Bispectral index, Different ages, Loss of consciousness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore dose requirements for loss of consciousness and bispectral index changes during general anesthesia induction with ciprofol in patients of different ages, providing a reference for its rational clinical application.
Detailed description
Ciprofol, a novel gamma-aminobutyric acid (GABA) receptor agonist, is structurally modified from propofol by adding a cyclopropyl group to its side chain, forming an R-type chiral structure. This modification enhances its affinity for GABA receptors, resulting in faster onset, rapid metabolism, higher potency, reduced injection pain, and milder respiratory/circulatory suppression. Ciprofol exhibits good safety and tolerability, smooth and rapid induction, complete recovery, and low incidence of injection pain, making it a promising alternative to propofol. Age is a critical factor influencing general anesthesia and anesthetic drug responses. Age-related changes in organ function affect pharmacokinetics and pharmacodynamics, leading to variations in required drug doses and characteristic electroencephalogram changes. Therefore, this study aims to compare ciprofol doses and BIS changes during general anesthesia induction across age groups, offering reference and guidance for clinical medication.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 120 patients scheduled for general anesthesia were selected according to inclusion/exclusion criteria, with balanced age distribution and equal gender allocation (60 males and 60 females).
Key inclusion criteria (1 listed)
- 1) The ASA classification I-II 2) BMI range: 18.5 < BMI ≤ 24.9 kg/m² 3) Scheduled for elective general anesthesia surgery 4) Signed informed consent by the patient or legal guardian
Key exclusion criteria (1 listed)
- 1) Patients with central nervous system disorders or using medications affecting the central nervous system 2) Patients with cardiac, hepatic, pulmonary, or renal dysfunction 3) History of alcohol or drug abuse 4) Allergy to the study drug 5) Patients with hematologic or metabolic diseases 6) Participation in other drug clinical trials within the past 4 weeks 7) Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It is an observational study without any intervention measures.All patients will fast for 6 hours and will abstain from drinking for 2 hours preoperatively, with no premedication. Preoxygenation will be performed with an oxygen flow rate of 6 L/min. Ciprofol will be continuously infused via a micropump at a rate of 12 mg/kg/h. During preoxygenation with a facemask, if respiratory depression occurs during ciprofol infusion, assisted ventilation via facemask will be initiated. After LOC and completion of observation indices, the anesthesiologist may administer midazolam (1-3 mg), sufentanil (0.2-0.5 μg/kg), and rocuronium (0.3-0.6 mg/kg) sequentially based on the patient's age, physical condition, and BIS values to complete anesthesia induction. If hypotension (systolic blood pressure <90 mmHg or <80% of baseline) or bradycardia (heart rate <50 beats/min) occurs during induction, vasoactive agents such as ephedrine or atropine will be administered for management. | Other | – |
Primary outcome
Ciprofol dosage
Time frame: During anesthetic Induction
Ciprofol dose required to achieve loss of consciousness. Ciprofol was continuously infused via a micropump at a rate of 12 mg/kg/h. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and loss of eyelash reflex were used to assess sedation depth, with evaluations performed every 5 seconds. A MOAA/S score ≤1 and loss of eyelash reflex were defined as loss of consciousness (LOC).
Bispectral index
Time frame: Baseline (Before surgery)
Bispectral index before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.
4 secondary outcomes
Mean arterial pressure (MAP)
Time frame: up to 3 minutes
heart rate (HR)
Time frame: up to 3 minutes
SpO₂
Time frame: up to 3 minutes
Incidence of adverse reactions including respiratory depression and injection pain
Time frame: Baseline (Before surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Ciprofol
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Recruiting
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Anesthesia, Sedation
Not yet recruiting
The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications
Intracranial Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ciprofol, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ciprofol dosage (time frame: During anesthetic Induction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.